FORMULATION AND EVALUATION OF OLANZAPINE SUBLINGUAL TABLETS USING SOLID DISPERSION TECHNIQUE

Abstract

Background: Olanzapine belongs to BCS Class II drugs characterized by low solubility and high permeability, which limits its therapeutic efficacy when administered orally. The sublingual route offers advantages including rapid absorption, avoidance of first-pass metabolism, and quick onset of action, making it particularly suitable for psychiatric emergencies.

Objective: The present study aimed to formulate and evaluate sublingual tablets of Olanzapine using solid dispersion technique to enhance solubility and achieve rapid drug release for the management of schizophrenia.

Methods: Solid dispersions were prepared using solvent evaporation method with PEG 6000 and propylene glycol as carriers. Sublingual tablets were formulated by direct compression method using various superdisintegrants including croscarmellose sodium (CCS), crospovidone (CP), and sodium starch glycolate (SSG). The formulations were evaluated for preformulation parameters, physical characteristics, in-vitro disintegration time, wetting time, and drug release studies.

Results: FTIR studies confirmed the absence of drug-excipient incompatibility. Solid dispersion with propylene glycol at 1:2 ratio showed maximum solubility enhancement (0.24 mg/mL). Among all formulations, batch F8 containing 5% sodium starch glycolate exhibited optimal characteristics with disintegration time of 15±3 seconds, wetting time of 15±1 seconds, and drug release of 98.19±0.44% within 10 minutes. Stability studies at 40°C/75% RH for 30 days confirmed the formulation stability.